Disease Team Research I

RFA 09-01:CIRM Disease Team Research Awards

The CIRM Disease Team Research Awards will fund actively managed multidisciplinary teams engaged in milestone-driven translational research for the development of stem cell-based therapies. The mission of these teams will be to conduct the necessary research and regulatory activities to prepare and file a complete, well supported Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) (and, if desired, other regulatory agencies), to enable Phase I clinical testing. The Disease Team Research Award is core to CIRM’s mission and as such, the agency will likely solicit applications every twelve to eighteen months as a way to build a strong clinical pipeline for patient therapies and cures. This RFA includes CIRM’s Collaborative Funding Partner Program, and the CIRM Loan Program.

Section III Award Information has been amended to clarify that $3 million to $20 million per project is the range for total funds requested (includes direct project costs, direct facilities costs, and indirect costs)

Preliminary Application Instructions and Forms

Submission of an application for the CIRM Disease Team Research Award involves a two step process in which an applicant first submits a Preliminary Application (Pre-Application; PreApp) and subsequently submits a full application only if invited to do so by CIRM. PreApps will be evaluated by scientific specialists from outside California who are experts in specific areas of research described in the PreApp and by CIRM scientific staff, based on scientific review criteria described in section VII of the RFA. Applicants whose projects are judged as most promising, competitive, and responsive to the RFA will be invited to submit a full application. Applicants who are not invited to submit a full application will be deferred.

Each applicant must submit a Pre-Application using the PreApp Form. In addition to the PreApp form, applicants must submit a Related Business Entities Disclosure Form. Each investigator may submit one preliminary application (PreApp, See Section VI) as either a PI or a Co-PI; and, the same investigator may be a Co-PI on up to one additional preliminary application. An investigator who applied as a PI on CIRM RFA 08-05 “Early Translational Research Award” is not eligible to apply as a PI, but may apply as a Co-PI on this award.

The completed PreApp form (less the Official signature) and the Related Business Entities Disclosure Form must be sent as interactive pdf documents (the original document format; documents must not be “flattened” or converted to another format) as email attachments to DiseaseTeamPreApp@CIRM.ca.gov and must be received by CIRM no later than 5:00 pm (PDT) on March 26, 2009. Additionally, a hard copy of the cover (first) page of the PreApp, signed by an institutional official authorized to sign on behalf of the applicant’s organization, must be received by CIRM no later than 5:00 pm (PDT), on March 26, 2009.

Applicants whose proposals include a CIRM/Funding Partner team must also send an electronic copy of this PreApp to the designated partner point-of-contact email listed in the Appendices of the RFA.

It is the applicant’s responsibility to meet this deadline; no exceptions will be made.

You will need a fully functional copy of Adobe Acrobat version 7 or 8 (Standard or Professional) to complete, print, and save the PreApp, Related Business Entities Disclosure Forms. We recommend using Adobe Acrobat version 8.1 (or the latest version). Using Adobe Acrobat Reader will not permit you to save information that is entered in the form.

Full Application Instructions and Forms

Full Applications will only be accepted from applicants who 1) submitted a PreApp and 2) are invited by CIRM to submit a Full Application.

The full application for the Disease Team Research Award consists of five parts: Part A: Application Information Form, Part B: Disease Team Award Research Proposal, Part C: Biographical Sketches for Key Personnel, Part D: Institutional Letter(s) of Commitment, and Part E: Related Business Entities Disclosure Form.

All five parts of the full application for CIRM Disease Team Research Awards must be submitted together and received by CIRM no later than 5:00 pm (PDT) on July 16, 2009, in both electronic form and in hard copy (a signed original and five copies). It is the applicant’s responsibility to meet this deadline;no exceptions for late applications will be made.

Send electronic copies of all parts of the application as attachments in a single email to DiseaseTeamResearchAwards@cirm.ca.gov. Applicants whose proposals include a CIRM/Funding Partner team must also send an electronic copy of the full application (Parts A-E) to the designated partner point-of-contact email listed in the Appendices of the RFA.

In addition to the electronic submission, candidates must submit an original copy of the application (consisting of Parts A-E) plus 5 copies of the full application (preferably double-sided) to the mailing address below. The original copy must be signed by both the PI and the applicant institution’s Authorized Organizational Official (AOO). Applications designating a Co-PI(s) must also be signed by the Co-PI and the Co-PI’s institutional AOO.

You will need a fully functional copy of Adobe Acrobat version 7 or 8 (Standard or Professional) to complete, print, and save Parts A and E of the Full Application. We recommend using Adobe Acrobat version 8.1 (or the latest version). Using Adobe Acrobat Reader will not permit you to save information that is entered in the form.